Sample test automation system

ABSTRACT

A sample test automation system which is capable of reducing the workload of an operator and precisely carrying out necessary processes of each of samples without stagnation. In the sample test automation system, a sample tray  120  on which a plurality of samples  150  can be installed is prepared, an identifier for distinguishing the sample tray  120  is attached to the sample tray  120 , a sample introducing unit  10  is provided with an identifier reading apparatus  111  which reads the identifier of the sample tray  120 , and information about the samples  150  is switched based on the read identifier of the sample tray  120.

TECHNICAL FIELD

The present invention relates to a sample test automation system thatprocesses samples of blood, urine, etc. in clinical tests andparticularly relates to sorting of the samples upon sample introduction.

The present invention also relates to a sample test automation systemprovided with a function of reducing recovery process operations in acase in which errors have occurred in the system.

BACKGROUND ART

The sample test automation system is a system which automates processessuch as centrifugal separation, decapping, aliquot sample aliquoting,barcode attaching, and aliquot sample sorting. The samples handled bythe sample test automation system are biological samples such as blood(whole blood, blood serum, blood plasma) and urine. The state of thesamples upon introduction into the sample test automation system isvarious, and processing contents are therefore different for eachsample.

Examples of actual management include: a situation in which the sampleswhich have undergone and not have undergone centrifugal separation aremixed, a case in which so-called Short Turn Around Time (STAT) sampleswhich require prioritized processing are suddenly inserted, and a casein which processing contents are different depending on the types of thesample containers. The processes having different contents have to becarried out for each of the samples in accordance with the management,respectively.

With respect to these needs, conventionally, a conveying method using asample rack on which a plurality of samples can be installed has beenemployed to manage information imparting to the rack. Through a methodof imparting information such as the types of samples (identification ofsample types, distinguishment of routine/calibrator/precision control)and processing contents to the range of the number of an identifierattached to the rack or the color or shape of the rack, samples areautomatically sorted to handle above-described various situations.

For example, in Japanese Patent Application Laid-Open Publication No.H11-083866 (Patent Document 1), a dedicated number is imparted to a rackon which STAT samples are placed, and the samples are conveyed tonecessary conveyance destinations based on the conveyance informationread from the rack. Japanese Patent Application Laid-Open PublicationNo. H11-304812 (Patent Document 2) describes a method of a measureagainst a case in which a reading error of the identifier of the rackoccurs.

Containers storing samples such as blood or urine are loaded on a rackor a container for conveying samples called a sample container holder orthe like and are supplied to the sample test automation system.Depending on the test items to be measured and the contents ofpreprocessing, the samples are subjected to, for example, a centrifugalseparation process, a decapping process of decapping caps of thecontainers, a process of aliquoting the sample to one or more differentcontainers, i.e., an aliquoting process from a primary sample to aliquotsample containers in accordance with use; a process of attaching barcodelabels on aliquot sample containers, a recapping process of closing thealiquot sample containers with the caps, a sorting storage process ofsorting primary samples and aliquot samples in accordance with theprocesses thereafter, and a process of conveying an aliquot sample rackto an automatic analyzing apparatus and analyzing and measuring aliquotsamples. Apparatuses having functions of these processes are connectedby a plurality of conveyance lines to constitute a sample testautomation system.

Such a sample test automation system is described in, for example,Japanese Patent Application Laid-Open Publication No. H7-167866 (PatentDocument 3).

In addition, the sample test automation system contributes to shiftingtest room operators to operations of higher value by significantlyautomating repeated operations in a test room. In operation of thissystem, some parts have not been completely automated yet. Typical onesinclude supply of consumable items, carry-in/out of samples, andrecovery processes upon error occurrence.

If an error occurs in the course of a process with respect to thesamples, the error-occurred samples have to be separated from normalsamples and taken out to outside the system. In Japanese PatentApplication Laid-Open Publication No. 2009-222535 (Patent Document 4),working efficiency is improved by customizing sample carrying-outdestinations on an automatic analyzing apparatus in accordance withmanagement. In Japanese Patent Application Laid-Open Publication No.2009-36643 (Patent Document 5), carrying-out patterns are controlledrespectively for types of samples, for example, respectively forpatients or hospital wards upon carry-out of the samples to sample traysto improve ease in handling of the samples.

PRIOR ART DOCUMENTS Patent Documents

-   Patent Document 1: Japanese Patent Application Laid-Open Publication    No. H11-083866-   Patent Document 2: Japanese Patent Application Laid-Open Publication    No. H11-304812-   Patent Document 3: Japanese Patent Application Laid-Open Publication    No. H7-167866-   Patent Document 4: Japanese Patent Application Laid-Open Publication    No. 2009-222535-   Patent Document 5: Japanese Patent Application Laid-Open Publication    No. 2009-36643

DISCLOSURE OF THE INVENTION Problems to be Solved by the Invention

Meanwhile, today, not only a conveyance system using the sample rack,but also a conveyance system using a sample holder on which only onesample is installed is also common. This conveyance system hasadvantages for individual processing of samples, for example, thesamples are not required to be collected in a rack, and delay ofprocesses and accompanying conveyance due to waiting for filling of therack can be avoided.

However, this conveyance system in this state is not suitable for massprocessing. Therefore, in order to prevent reduction in processingability, a sample tray on which a plurality of samples can be installedhas been conventionally employed in a sample introducing unit as meansfor substituting for the rack. Different uses of sample trays such asthose carried out in the conventional conveyance systems using racks asdescribed in Patent Documents 1 and 2 are not employed. Therefore, forindividual samples, the samples and the information about the samplessuch as processing methods have to be input in detail through a screenof an operation unit, and the load of operators is large.

In this manner, conventionally, there has been a problem that theoperation of inputting related information has been required for everysample upon introduction of samples in the system that carries outconveyance by the sample holder on which only one sample is installed.

Moreover, a primary sample of which preprocessing has been finished isnormally sorted in a sorting process and set to a predetermined tray;or, if the container for conveying the primary sample is, for example, arack, the primary sample is stored in a state that it is installed inthe rack.

If an add-on test or addition of test items is ordered from a test roominformation system (Laboratory Information System, hereinafter,abbreviated as LIS), which is a higher-order system of the sample testautomation system, the current position of the primary sample issearched by using a monitor of an operation unit provided in the sampletest automation system, and, by manual operation, the primary sample istaken out from the tray or the rack on which the primary sample isinstalled is taken out from the searched and found out location and isintroduced again to an introducing unit to carry out management.However, many sample containers and sample racks are arranged in thestoring location of the primary sample, and the operation of taking outthe objective primary sample or the rack on which the primary sample isinstalled by manual operation is not only cumbersome and non-efficient,but can also induce human errors such as mix-up of samples. Also, therisk of infection caused by direct contact with the samples isconceivable.

Furthermore, since the carrying-out destinations of error samples havebeen fixed in conventional systems, the carrying-out location of theerror samples and the carrying-in locations after recovery processes aredistant from each other depending on the system layout, the movingdistance of operators is long, and working efficiency has been reducedin some cases.

When a recovery process operation of a sample for which some sort oferror has occurred is to be carried out in the sample test automationsystem, in the current sample test automation system, the operator hasto see a screen or a record file in order to find out what kind ofrecovery process should be carried out.

In a case in which an error sample is generated, if an alarm isgenerated immediately after the error has occurred in the deviceconfiguration in which various processing units and a carrying-outlocation of the error sample are distant from each other, the operatorarrives at the carrying-out location before the error sample arrives atthe carrying-out destination, and the operator has to wait in somecases.

In view of the above-described problems, it is a preferred aim of thepresent invention to provide a sample test automation system capable ofproposing a uniformed sample recognizing method, reducing the workloadof operators, and precisely carrying out processes respectively requiredfor samples without stagnation.

It is another preferred aim of the present invention to provide a sampletest automation system that realizes simple operation while preventingmix-up of samples by manual operation of test technicians who are systemusers and avoiding the risk of infection.

The above and other preferred aims and novel characteristics of thepresent invention will be apparent from the description of the presentspecification and the accompanying drawings.

Means for Solving the Problems

A summary of the inventions disclosed in the present application will bebriefly described as follows.

Specifically, a sample tray on which a plurality of samples can beinstalled is prepared; an identifier for distinguishing the sample trayis attached to the sample tray, a sample introducing unit has anidentifier reading apparatus that reads the identifier attached to thesample tray; and an operation control unit switches and controlsinformation about the samples installed on the sample tray based on theidentifier attached to the sample tray, the identifier having been readby the identifier reading apparatus. An outline of the present inventionfor achieving above-described another object will be explained as below.

More specifically, sample test automation system includes: anintroducing unit that introduces samples; a processing unit thatpreprocesses the samples; a storage unit that storespreprocessing-finished samples; a sample conveyance line that conveysthe samples between the introducing unit; the processing unit, and thestorage unit; and an operation unit that controls the introducing unit,the processing unit, and the storage unit; using trays that can beshared by the introducing unit and the storage unit. The tray isprovided with an identifier storing identification information about thetray per se and the samples installed on the tray. An apparatus thatreads/writes the identification information from/to the identifier bymeans such as wireless communication is installed at the introducingunit and the storage unit. A mechanism that writes the latestidentification information about the sample installed on the tray and atleast the usage state of the tray to the identifier when an operation oftaking out the tray is carried out in the storage unit is provided. Amechanism that reads the identification information about the sampleinstalled on the tray and at least the usage state of the tray from theidentifier when an operation of introducing the tray is carried out inthe introducing unit is provided. An operation unit that has means forcommunicating with the introducing unit and the storage unit and has acontrol process of sending various orders to the introducing unit andthe storage unit as a result of sending/receiving of the identificationinformation by the communication means is provided. The operation unitis provided with a function of notifying a test technician of the factthat the sample for which an add-on test or addition of a test item isto be carried out is installed on the tray taken out from the storageunit; and the operation unit is provided with a function of notifyingthe test technician of the fact that the sample to be re-transferred(re-reformatted) is not installed on the tray introduced to theintroducing unit. Other outlines of the invention disclosed in thepresent application will be explained as follows.

A mechanism capable of arbitrarily setting the carrying-out destinationof an error sample in accordance with layout or management is provided.As a result, a layout or workflow taking, for example, the movingdistance to the position of a working desk in a test room or to are-carry-in location after finishing a recovery process by manualoperation into consideration can be achieved.

Moreover, a mechanism that distinguishes a conveyance destination foreach of the types and recovery processing methods of error samples isprovided. As a result, the type or recovery method of the error can befound out from the conveyance destination; therefore, the operator isnot required to see a screen or a record file upon a recovery process.

Moreover, means for changing the timing of an error notification to thetiming when the error sample is carried out instead of the timing ofgeneration of the error sample is provided.

In accordance with the management mode of the test room which is afacility utilizing the system, the processing unit is provided with agroup of required apparatuses, and the sample test automation systemcapable of handling various processes can be built. In the presentspecification, descriptions about components of the processing unit willbe omitted; however, every processing apparatus does not impair therange of implementation influence of the present invention.

Effects of the Invention

The effects obtained by typical aspects of the present invention will bebriefly described below.

An effect obtained by typical aspects is that each sample can beindividually subjected to a process having different contents byswitching the sample information based on the identifier attached to thesample tray on which samples are installed. When the operator onceregisters the information linked to the information about the identifierattached to the sample tray and about the sample, the operation ofinputting processing contents every time for each sample becomesunnecessary in the management thereafter. Since the function by whichthe operator can arbitrarily set a management method is provided,management adapted for the individual environment of a test room can becarried out.

Effects obtained by another invention disclosed in the presentapplication will be described below.

In the sample test automation system, simple operability can be realizedwhile preventing mix-up of samples by manual operation and avoiding therisk of infection.

Moreover, according to the present invention, the conveyance destinationcan be also customized depending on the layout or management of eachtest room; therefore, the moving route of operators can be optimized toimprove working efficiency.

Moreover, since the carrying-out destinations of the error samples aresorted for each type or recovery processing method, the operator canimmediately start a recovery operation at the point when he/she touchesthe error sample without seeing a screen or a record file.

Furthermore, when the operator arrives at the carrying-out destinationof the error samples, the error samples have already arrived always;therefore, wasteful waiting time is not generated.

According to combinations of the foregoing, the recovery operation forthe error samples in the sample test automation system according to thepresent invention can be more smoothly carried out. Furthermore, theeffect of reduction in operation errors can be also expected since thereferencing operation is eliminated.

BRIEF DESCRIPTIONS OF THE DRAWINGS

FIG. 1 is a configuration diagram illustrating an overall configurationof a sample test automation system according to an embodiment of thepresent invention;

FIG. 2 is a configuration diagram illustrating a configuration of asample introducing unit of the sample test automation system accordingto the embodiment of the present invention;

FIG. 3 is a diagram illustrating an example of a sample tray of thesample test automation system according to the embodiment of the presentinvention;

FIG. 4 is a diagram illustrating an example of a sample holder of thesample test automation system according to the embodiment of the presentinvention;

FIG. 5 is a diagram illustrating an example of a sample of the sampletest automation system according to the embodiment of the presentinvention;

FIG. 6 is an explanatory diagram for explaining a method of attachingidentifiers to trays of the sample test automation system according tothe embodiment of the present invention;

FIG. 7 is an explanatory diagram for explaining a method of attachingthe identifiers to the trays of the sample test automation systemaccording to the embodiment of the present invention;

FIG. 8 is an explanatory diagram for explaining a method of impartinginformation to locations of the sample test automation system accordingto the embodiment of the present invention;

FIG. 9 is an explanatory diagram for explaining a method of logicallycompartmentalizing the trays of the sample test automation systemaccording to the embodiment of the present invention;

FIG. 10 is a diagram illustrating an example of a first layer screen ofa setting screen of a sample test automation system according to theembodiment of the present invention;

FIG. 11 is a diagram illustrating an example of a second layer screen ofthe setting screen of the sample test automation system according to theembodiment of the present invention;

FIG. 12 is a diagram illustrating an example of a third layer screen ofthe setting screen of the sample test automation system according to theembodiment of the present invention;

FIG. 13 is a diagram illustrating an example of a third layer screen ofthe setting screen of the sample test automation system according to theembodiment of the present invention;

FIG. 14 is a diagram illustrating an example of another second layerscreen of the setting screen of the sample test automation systemaccording to the embodiment of the present invention;

FIG. 15 is a diagram illustrating an example of another third layerscreen of the setting screen of the sample test automation systemaccording to the embodiment of the present invention;

FIG. 16 is a diagram illustrating an example of the tray of the sampletest automation system according to the embodiment of the presentinvention;

FIG. 17 is a diagram illustrating an example of the tray of the sampletest automation system according to the embodiment of the presentinvention;

FIG. 18 is a block diagram illustrating a configuration example of anonline system adopting the embodiment of the sample test automationsystem of the present invention;

FIG. 19 is a diagram illustrating an internal structure example of anintroducing unit and a storage unit;

FIG. 20 is a diagram illustrating an internal structure example of theintroducing unit and the storage unit;

FIG. 21 is a flow chart illustrating a judging process for prioritizingan add-on test or additional test in the introducing unit;

FIG. 22 is a schematic diagram illustrating a cooperation example of asample test automation system composed of a plurality of systems;

FIG. 23 is a diagram illustrating an example of a state viewing a trayof 5×10 from directly above;

FIG. 24 is a diagram illustrating a screen example of storage unit traysetting parameters displayed by an operation unit;

FIG. 25 is a diagram illustrating an example of a tray informationinitializing screen displayed by the operation unit;

FIG. 26 is a diagram illustrating an example of a tray expire dateparameter screen displayed by the operation unit;

FIG. 27 is an overall schematic diagram of a sample test automationsystem which is an embodiment of the present invention;

FIG. 28 is a configuration diagram of a sample introducing unit;

FIG. 29 is a configuration diagram of a sorting unit;

FIG. 30 shows a setting example of types of error samples and conveyancedestinations;

FIG. 31 is a diagram illustrating an example of carrying-outdestinations of the error samples according to FIG. 30 illustrated in awhole system;

FIG. 32 is a diagram illustrating an example of the carrying-outdestinations of the error samples in a sample tray according to FIG. 30;

FIG. 33 is a diagram illustrating an example of carrying out an errorsample upon aliquoting failure;

FIG. 34 is a diagram illustrating Example 1 in which two different typesof samples dynamically share the sample tray;

FIG. 35 is a diagram illustrating Example 2 in which two different typesof samples dynamically share the sample tray;

FIG. 36 is a diagram illustrating an example of the sample tray of alayout in which holes are shifted by one column or one row; and

FIG. 37 is a diagram illustrating an example in which two differenttypes of samples dynamically share the sample tray with one or morecolumns interposed therebetween.

BEST MODE FOR CARRYING OUT THE INVENTION

Hereinafter, embodiments of the present invention will be described indetail with reference to the accompanying drawings. Note that componentshaving the same function are denoted by the same reference symbols inprinciple throughout the drawings for describing the embodiment, and therepetitive description thereof will be omitted.

<1. System Outline>

According to FIGS. 1 to 5, a configuration of a sample test automationsystem according to an embodiment of the present invention will bedescribed. FIG. 1 is a configuration diagram illustrating an overallconfiguration of the sample test automation system according to theembodiment of the present invention, FIG. 2 is a configuration diagramillustrating a configuration of a sample introducing unit of the sampletest automation system according to the embodiment of the presentinvention, FIG. 3 is a diagram illustrating an example of a sample trayof the sample test automation system according to the embodiment of thepresent invention, FIG. 4 is a diagram illustrating an example of asample holder of the sample test automation system according to theembodiment of the present invention, and FIG. 5 is a diagramillustrating an example of a sample of the sample test automation systemaccording to the embodiment of the present invention.

In FIG. 1, the sample test automation system 1 is composed of the sampleintroducing unit 10, a centrifugal unit 20, a decapping unit 30, abarcode attaching unit 40, an aliquoting unit 50, a recapping unit 60, asorting unit 70, a sample storage unit 80, a conveying unit 2, and anoperation control unit (operating personal computer) 90, which carriesout operation and control of the whole sample test automation system 1.The configuration illustrated in FIG. 1 is an example and is notintended to limit them to the layout illustrated herein.

In the sample introducing unit 10, samples are introduced into thesample test automation system 1; and, in the centrifugal unit 20, theintroduced samples are subjected to centrifugal separation. In thedecapping unit 30, caps of the samples, which have undergone centrifugalseparation, are opened; and, in the aliquoting unit 50, the samples,which have undergone centrifugal separation, are separated into smallportions in order to subject them to analysis by, for example, externalanalyzing apparatuses. In the barcode attaching unit 40, barcodes areattached onto containers of the small portions.

In the recapping unit 60, the samples are closed with the caps; and, inthe sample storage unit 80, the samples closed with the caps are stored.In the sorting unit 70, aliquoted sample containers are sorted.

In FIG. 2, the sample introducing unit 10 is mainly composed ofelements, i.e., the conveying unit 2, tray storage units 110 (110 a, 110b), sample trays 120, an arm 130, and sample holders 140. Samples (testtubes/blood collection tubes) 150 are installed on the sample trays 120.

In FIG. 2, the tray storage units 110 denoted with 110 a show a state inwhich the sample tray 120 is stored in the tray storage unit 110 and thetray storage units 110 denoted with 110 b show a state in which nosample tray 120 is housed in the tray storage unit 110.

As illustrated in FIG. 3, the sample tray 120 is provided with aplurality of sample storage holes 121. Further, as illustrated in FIG.4, the sample holder 140 is composed of a base 141, an outer wall 142,and supports 143. Furthermore, as illustrated in FIG. 5, an identifiersuch as a barcode 151 is attached on the sample 150.

The conveying unit 2 conveys the sample holder 140 illustrated in FIG. 4along a path. In the present embodiment, the sample holders are conveyedin the direction of an arrow 21 in FIG. 2. The sample tray 120 is housedin the tray storage unit 110 (110 a, 110 b). A sensor (identifierreading apparatus) 111 is installed at a bottom part of the tray storageunit 110 (110 a, 110 b).

Although not illustrated in FIG. 2, an identifier is attached to thebottom of the sample tray 120, and a mechanism that reads the identifierby the sensor (identifier reading apparatus) 111 at the same time asinstallation is implemented.

For example, a one-dimensional barcode, two-dimensional barcode, or RFIDis adopted as the identifier.

As illustrated in FIG. 3, the plurality of sample storage holes 121 areprovided on the sample tray 120, and the samples 150 corresponding tothe maximum number of the holes can be installed therein. Belts areinstalled at the arm 130, and the arm can be moved lengthwise,widthwise, and vertically via motors (131, 132).

An operator installs the samples 150, to which the identifiers areattached, on the sample tray 120 and sets that in the sample introducingunit 10. This setting serves as a signal to start an automation processby the apparatus. The sample introducing unit 10 picks up the samples150 on the sample tray 120 by the arm 130 and installs the samples inthe sample holders 140 prepared on the conveying unit 2.

The base 141 in a circular shape as illustrated in FIG. 4 is attached tothe sample holder 140, and the sample holder can be therefore moved onthe conveying unit 2 without deviating therefrom. The diameter of theouter wall 142 has a fixed value, and the supports 143 are attachedthereto so that the sample 150 having a different diameter can beinstalled therein.

Then, the samples 150 are placed on the sample holders 140 andsequentially go through, for example, the centrifugal unit 20, thedecapping unit 30, the barcode attaching unit 40, the aliquoting unit50, the recapping unit 60, the sorting unit 70, and the sample storageunit 80 to undergo processes in the respective parts.

When the samples 150 are to be picked up in the sample introducing unit10, the sample storage holes 121 are sequentially probed in each sampletray 120 from the left back to the right front thereof; and, if nosample 150 is detected consecutively in a predetermined number or moreof the sample storage holes 121, it is considered that this sample tray120 has no sample 150, and probing of the next tray 120 is carried out.Alternatively, a method of installing a camera from the upper surface ofthe sample introducing unit 10 and installing a function thatautomatically recognizes the sample storage holes 121 with the samples150 is also effective.

<2. Switching of Information about Samples and Management Method>

Next, switching of information about the samples of the sample testautomation system according to the embodiment of the present inventionand a management method will be described with reference to FIGS. 6 to9. FIGS. 6 and 7 are explanatory diagrams for explaining a method ofattaching the identifiers to the trays of the sample test automationsystem according to the embodiment of the present invention, FIG. 8 isan explanatory diagram for explaining a method of imparting informationto locations of the sample test automation system according to theembodiment of the present invention, and FIG. 9 is an explanatorydiagram for explaining a method of logically compartmentalizing thetrays of the sample automation system according to the embodiment of thepresent invention.

The course of processes of the samples is determined according toinformation such as the types of the samples, the degrees of urgency,etc. The samples include not only patient samples but also calibratorsand precision control samples as samples for controlling the system, andit is important to identify them and cause the system to recognize them.

In the present embodiment, the above-described types of the samples areidentified, and the sample test automation system is caused to recognizethe information about the samples such as processing contents by afollowing method.

First, under the premise on all the above-described operations, anoperator links the identifiers and the information about the samples toeach other in advance and inputs the information from the operationcontrol unit 90 to register the information. The contents of theoperations are only required to be input once upon purchase or uponmaintenance of the sample test automation system and are saved even whenthe power supply of the sample test automation system is turned off.Once the information is registered, constant management in accordancewith setting is carried out unless the information is changedthereafter.

(1) Method of Attaching Identifier to the Sample Trays 120

(i) Method of Attaching Identifiers Composed of Two-Digit NumericalValues to the Sample Trays 120

As a method of attaching identifiers each of which is composed of atwo-digit numerical value to the sample trays 120, the identifiers areattached to the sample trays 120 based on a table 161 as illustrated inFIG. 6 in which the identifiers 164, the types 162 of the sample, andprocess information 163 about processes are mutually linked.

Herein, the types 162 of the samples include blood serum, blood plasma,and urine; and the process information 163 includes a routine (normal)process, the necessity of a centrifugal separation process, thenecessity of decapping, and urgency (priority). The range of the numbersof the corresponding identifiers is described in the region of theidentifiers 164.

The table illustrated in FIG. 6 can be optionally set/changed by theoperator or a serviceman and is determined in consideration of thecircumstances in each test room. For example, in a test room in whichthe objects to be handled are specialized for blood analysis, all of thevertical parts about “urine” can be set to “0-0” so that only theelements about blood can be selected.

Also, in a test room in which only the samples which have alreadyundergone centrifugal separation are handled, all of the horizontalparts about “routine” are set to “0-0”. The range of the values of thecorresponding identifiers should be set based on the information of thenumber of handled samples.

Then, the identifiers and the processing contents are mutually linked,and the contents are registered in the sample test automation system.For example, for the trays of which values of the identifiers are 41 to49, the processes that skip the centrifugal unit are registered to becarried out since the samples installed thereon have already undergonecentrifugal separation. For the trays of which values of the identifiersare 51 to 59, registration is carried out so as to skip the decappingunit since no caps are recapped to the installed samples. The trays ofwhich values of the identifiers are 91 to 99 are STAT samples andregistered to be processed as first priority.

The operator is only required to install the samples 150 on theappropriate tray(s) 120 in accordance with the contents set byhimself/herself. For example, in the case of the samples 150 of wholeblood which are the samples 150 which have already undergone centrifugalseparation or the samples 150 which do not require centrifugalseparation, the samples 150 are installed on the sample tray 120 ofwhich value of the identifier is 41 to 44. In the case of the samples150 of urine with no caps, the samples are installed on the sample tray120 of which value of the identifier is 58 or 59. The STAT samples 150are installed on the sample tray 120 of which a value of the identifieris in the nineties.

Next, the sample-installed sample tray 120 is set in the tray storageunit 110 b, in which no sample tray 120 is installed, in the sampleintroducing unit 10. A signal that indicates that the sample tray 120has been set in the sample introducing unit 10 serves as a trigger tostart a process.

First, the identifier reading apparatus 111 at the bottom of the traystorage unit 110 b reads the identifier of the sample tray 120. Based oncontents which have been registered in advance, the sample testautomation system 1 recognizes the processing contents of each of thesamples 150 according to the information of the read identifier of thetray and positional information of the picked up sample.

For example, the sample 150 picked up from the sample tray 120 of whichthe identifier is 41 to 44 is processed while skipping the centrifugalunit. The sample 150 picked up from the sample tray 120 of which theidentifier is 58 or 59 is processed while skipping the decapping unit.Alternatively, the processing of the sample installed on the sample tray120 of which the identifier is in the nineties is prioritized over allthe others.

When management is carried out in the above-described manner, uniformprocesses can be carried out without individually inputting theinformation of the samples to the sample test automation system.

(ii) Method of Attaching Identifiers Composed of Multi-Digit NumericalValues to the Sample Tray 120

As a method of attaching identifiers composed of multi-digit numericalvalues to the sample tray 120, the identifiers are attached to thesample tray 120 based on a table 170 as illustrated in FIG. 7 in whichthe types, processes, etc. of the samples are associated with respectivedigits of the multi-digit numerical values. The example illustrated inFIG. 7 describes an example in which each of the identifiers is composedof a seven-digit numerical value. Details can be set by using themulti-digit numerical value.

Information about the sample is imparted to the numbers of the digitsillustrated in FIG. 7. For example, the type of the sample is impartedto a first digit 171, the necessity of a centrifugal process is impartedto a second digit 172, the necessity of a decapping process is impartedto a third digit 173, the necessity of a recapping process is impartedto a fourth digit 174, the information of a conveyance destination isimparted to a fifth digit 175, the information about priority of theprocesses is imparted to a sixth digit 176, and the information aboutthe shape of the container of the sample (type of the container) isimparted to a seventh digit 177.

These setting items can be optionally selected, contents thereof can beoptionally set, and these are determined in consideration of thecircumstances in each test room.

Then, the numerical values of the digits of the identifier andprocessing contents, types, etc. are mutually linked, and the contentsillustrated in FIG. 7 are registered in the sample test automationsystem.

Then, in accordance with the setting contents, the samples 150 areinstalled on the sample tray 120, which is appropriate. Then, thesample-installed sample tray 120 is set in the tray storage unit 110 bof the sample introducing unit 10.

When the sample tray 120 is set, the identifier of the sample tray 120is read through the identifier reading apparatus 111, and this serves asa trigger to start processes. According to the information of the readtray identifier and the positional information of the picked up sample,the sample test automation system 1 can recognize the processingcontents based on the above-described contents registered in advance. Inthis manner, the sample test automation system which carries outappropriate processes for each sample can be provided.

In order to avoid intermediation of human errors of the operator withrespect to these operations, a method in which display by characters isadded in accordance with needs in addition to symbols of the identifiersis also effective. Coloring the trays is also an effective way toprevent mistakes.

Furthermore, other than the specific examples illustrated in FIGS. 6 and7, a method that incorporates a method in which calibrators andprecision control samples for controlling the system are distinguishedfrom routine samples collected from patients is also effective (FIG.16).

In the case in which samples collected from a single patient with aplurality of blood collection tubes are to be introduced, a method inwhich a processing course omitting a redundancy check, which is a normalessential function, is provided for the sample of the second tube isalso effective. Adopting a mechanism which distinguishes the sample ofthe second tube from samples of add-on tests is also effective (FIG.17).

Adopting a method which enables introduction of manually-aliquotedaliquot samples directly to the system is also effective (FIG. 17).

(2) Method of Imparting Information to Locations

(i) Method of Imparting Information to Disposed Locations of the SampleTrays 120

As a method of imparting information to the disposed locations of thesample trays 120, the installed locations of the sample trays 120 in thesample introducing unit 10 and the processing contents are caused tocorrespond to each other. For example, as illustrated in FIG. 8, eighttray-disposed locations are compartmentalized into five (181 to 185)regions.

The number of compartments and the areas thereof can be arbitrarilyspecified in accordance with the corresponding processing contents andthe number of processes and should be set in consideration of thecircumstances of a used hospital or test center.

Then, the locations of the sample trays 120 and the processing contentsare mutually linked and registered. For example, the samples 150 of thetype most frequently introduced to the sample test automation system arecaused to correspond to a region 181 having the largest area. In fact, aseries of processes of separating blood serum from the blood of wholeblood collected from patients and aliquoting (separation into smallportions) that is a process frequently carried out in many test rooms.The samples 150 set in the region 181 are registered to carry outprocesses as “routine processes”.

In addition, in a large test center that undertakes componentialanalysis of blood, the samples 150 which have undergone centrifugalseparation are sometimes handled. A region 182 serves as a region inwhich the samples 150 which have already undergone centrifugalseparation are set, and the samples placed in the region 182 areregistered to skip the centrifugal separation process. Similarly, aregion 183 for handling the samples 150 with no caps, a region 184 forhandling the samples 150 such as urine other than blood, and a region185 for handling STAT samples are reserved, and respective processingcontents (for example, skipping the decapping unit or processing asfirst priority) are registered.

The operator is only required to install the samples 150 at appropriatelocations on the sample trays 120 in accordance with the contents set byhimself/herself. For example, whole blood samples are installed in theregion 181, the samples 150 which do not require centrifugal separationare installed in the region 182, no-cap samples are installed in theregion 183, urine samples are installed in the region 184, and STATsamples are installed in the region 185, respectively.

The installation of the samples 150 serves as a trigger to start theprocesses. According to positional information of the sample tray 120 ofthe picked up sample 150, the sample test automation system 1 recognizesthe processing contents of each sample 150 based on the contentsregistered in advance.

For example, the samples 150 installed on the sample tray 120 of theregion 181 are subjected to routine processes. The samples installed inthe sample tray 120 of the region 182 skip the centrifugal unit. Thesamples installed on the sample tray 120 of the region 183 skip thedecapping unit. The samples installed on the sample tray 120 of theregion 184 are processed as first priority.

Note that the correspondence depending on the types of the samples 150has been described in this case. However, a different use usingdifferences in the shapes of the caps, differences in the processingcontents, etc. as keys may be adopted.

When management is carried out in the above-described manner, uniformprocesses can be carried out without individually inputting theinformation of the samples to the sample test automation system.

(ii) Method of Logically Compartmentalizing the Sample Tray 120

As a method of logically compartmentalizing the sample tray 120, thesample tray 120 is logically compartmentalized so that positions thereofcorrespond to processing contents. For example, as illustrated in FIG.9, the sample tray 120 is compartmentalized into four (186 to 189).

The number of compartments and the areas thereof can be arbitrarilyspecified in accordance with the corresponding processing contents andthe number of processes and should be set in consideration of thecircumstances of a using hospital or test center.

Then, the locations in the compartments in the sample tray 120 and theprocessing contents are mutually linked and registered. For example, thesamples 150 set in a region 1 (186) are registered to be processed as“routine processes”. A region 2 (187) serves as a region in which thesamples 150 which have already undergone centrifugal separation are set,and the samples placed in the region 187 are registered to skip thecentrifugal separation process. Similarly, a region 3 (188) isregistered as a region for handling the samples 150 of urine, and aregion 4 (189) is registered as a region for handling STAT samples.

When management is carried out in the above-described manner, uniformprocesses can be carried out without individually inputting theinformation of the samples to the sample test automation system. Moredetailed separation can be carried out by further compartmentalizing thesample tray 120 into a plurality of compartments.

In the method of logically compartmentalizing the sample tray 120, themethod of imparting the information to the disposed locations of thesample trays 120 may be employed in combination so that the sample trays120 are logically compartmentalized at particular disposed locations ofthe sample trays 120.

<3. Setting Screen>

Next, examples of setting screens of the sample test automation systemaccording to the embodiment of the present invention will be describedwith reference to FIGS. 10 to 15. FIGS. 10 to 15 show examples ofscreens for describing the examples of the setting screens of the sampletest automation system according to the embodiment of the presentinvention. FIG. 10 shows the example of a first layer screen of thesetting screen, FIG. 11 shows the example of a second layer screen ofthe setting screen, FIGS. 12 and 13 show the examples of third layerscreens of the setting screens, FIG. 14 shows the example of anothersecond layer screen of the setting screen, and FIG. 15 shows the exampleof another third layer screen of the setting screen.

The operator can set above-described various contents through thesetting screens as illustrated in FIGS. 10 to 15.

First, the setting screen 201 illustrated in FIG. 10 serves as a firstlayer of the setting screen. The setting screen 201 is composed of abutton for imparting the information to the identifiers of the trays((1) button for selecting the method of attaching the identifiers to thesample trays 120) 202 and a button for imparting the information to thetray disposed positions of the introducing unit ((2) button forselecting the method of imparting the information to the locations) 203.

(i) Selecting the Button 202 for Selecting the Method of Attaching theIdentifiers to the Sample Trays 120

When the button 202 is pressed, the setting screen 211 of a second layerof the setting screen as illustrated in FIG. 11 is displayed. Thesetting screen 211 of the second layer is composed of elements, i.e., aninitializing button 212, a setting button 213, a detail button 214, anda table 215 displaying setting contents.

When the initializing button 212 among them is pressed, all of thenumerical-value parts of the displayed table are cleared. Then, when thesetting button 213 is pressed, the setting screen 221 of a third layeras illustrated in FIG. 12 is displayed.

In the setting screen 221 of the third layer, numerical values can beinput via input cells 222 for the contents explained in theabove-described method of attaching the identifiers composed of thetwo-digit numerical values to the sample trays 120. The maximum numberof the digits which can be input is adjusted in advance by the scale ofa facility which uses the sample test automation system.

After necessary items are input, a registration button 223 is pressed.Then, the information is stored in the sample test automation system,the screen is switched to the setting screen 211 of the second layerillustrated in FIG. 11, and the updated contents are displayed as thetable 215.

If the detail button 214 is pressed in the setting screen 211 of thesecond layer illustrated in FIG. 11, for example, the different settingscreen 224 of the third layer as illustrated in FIG. 13 is displayed,and the contents explained in the above-described method of attachingthe identifiers composed of the multi-digit numerical values to thesample trays 120 can be set. The numerical values desired to be set areinput via input cells 225; and, when a registration button 226 ispressed after input of necessary items is finished, the information isupdated in the sample test automation system.

(ii) Selecting the Button 203 for Selecting the Method of Imparting theInformation to the Locations

When the button 203 is pressed, another setting screen 231 of the secondlayer as illustrated in FIG. 14 is displayed. In this setting screen231, the contents explained in the above-described method of impartingthe information to the disposed locations of the sample trays 120 areset. The setting screen 231 is composed of buttons 232 for inputting thetypes of the samples 150, icons 233 of the sample trays 120, aregistration button 234, and a detail button 235.

The icons 233 of the sample trays 120 are displayed by the same layoutas that of the trays in the sample introducing unit 10. In the presentembodiment, the number of the trays in the sample introducing unit 10 iseight, and the eight icons are therefore prepared. When the icon to beselected is selected, it becomes an active state. Then, the button 232for inputting the type of the sample 150 is selected and pressed. Forexample, when the leftmost upper tray is to be set for STAT samples, theleftmost upper icon should be made active by clicking, and the STATsample button (the second top button of the buttons 232) should bepressed.

The set icon is displayed by the same color as that of the button. Whennecessary input is finished, the registration button 234 is pressed.When the detail button 235 is pressed with respect to the active sampletray 120, the screen is switched to a setting screen 236 of the thirdlayer as illustrated in FIG. 15. In this setting screen 236, thecontents explained in the above-described method of logicallycompartmentalizing the sample tray 120 are set.

Herein, the types of the samples can be registered for all of the samplestorage holes 121 by using an icon 237 of the activated tray and icons238 representing the sample storage holes 121. Each of the holes is madeactive, and the contents to be set are selected from the buttons 232 forinputting the types of the samples. In this process, in order to reduceredundant operations of the operator, multiple holes can be selected atthe same time. In order to reflect the set contents to the sample testautomation system, a registration button 239 is pressed.

In the above-described manner, the operator is enabled to easily carryout the setting for which the persons who can carry out the setting havebeen conventionally limited only to servicemen. The designs of thescreens are not limited to those of the setting screens of FIGS. 10 to15.

FIG. 18 is a block diagram illustrating a configuration example of anonline system, which adopts the embodiment of the sample test automationsystem of the present invention.

The online system illustrated in FIG. 18 is provided with automaticanalyzing apparatuses 280, which automatically analyze samples, and asample test automation system 260, which preprocesses samples into modesappropriate for analysis and supplies the samples to the automaticanalyzing apparatus 280.

The sample test automation system 260 is provided with: an introducingunit 261; a processing unit 262 illustrated with omitting detailedcomponents; a storage unit 263; an operation unit 267 provided with amonitor 264, a speaker 265, and communication means 266 with theapparatuses; and a conveyance line 268, which conveys the samples fromthe introducing unit 261 to the processing unit 262, the storage unit263, and the automatic analyzing apparatuses 280.

The automatic analyzing apparatuses 280 include a model of the mode inwhich samples are automatically supplied from the sample test automationsystem 260 by the conveyance line 268 like “AUTOMATIC ANALYZINGAPPARATUS 1” and “AUTOMATIC ANALYZING APPARATUS 2” in the drawing and amodel of the mode in which samples are supplied by manual operationsince it is not connected by the conveyance line 268 like “AUTOMATICANALYZING APPARATUS n” in the drawing.

The operation unit 267 receives request attribute information from anLIS 270, updates a sample information DB (database), controls theapparatuses by the communication means 266, screen-displays events suchas an alarm generated in the sample test automation system by themonitor 264, and notifies test technicians of event occurrence bygenerating sounds by the speaker 265.

The introducing unit 261 is a module, which introduces a tray on which aplurality of samples to be subjected to preprocessing are installed, andcorresponds to an inlet of the online system. Although not illustratedin the drawing, the introducing unit is provided with a mechanism whichsets the samples from the tray to a conveyance route. Regarding thesamples set to the conveyance route, identification information of thesamples is read by an identification information reading means (forexample, mainly, barcode reading apparatus), which is not illustrated inthe drawing, and is transmitted to the operation unit 267. The operationunit 267 searches the sample information DB whether request attributioninformation of the samples has already been received or not andtransmits arrival information, which indicates whether the requestattribute information has already been received or not, to the LIS 270serving as a high-order system. In the case in which a request has notbeen made in the operation unit 267 yet, the request attributeinformation of the sample is transmitted from the LIS 270 to theoperation unit 267. When a test item(s) to be preprocessed in theprocessing unit 262 or a test item(s) to be analyzed and measured in theautomatic analyzing apparatus 280 is received according to this requestattribute information, the operation unit 267 sends an order to theintroducing unit 261 so that the sample is transferred (reformatted) tothe conveyance line 268 and conveyed to the processing unit 262.

Although detailed components are omitted in FIG. 18, the processing unit262 is composed of various processing apparatus in accordance withmanagement needs of test rooms.

FIGS. 19 and 20 illustrate internal structure examples illustratingembodiments of the introducing unit 261 and the storage unit 263. Thetrays 271 are respectively equipped with RFID tags as identifiers (notillustrated), and the trays 271 are configured to be pulled out bysliding to the front side of the apparatus by drawer units 272.

A tray installation base 273 is provided with antennas 274 at each ofthe positions where the tray 271 is installed and sends/receivesinformation to/from an RFID tag provided on the tray 271. Theintroducing unit 261 and the storage unit 263 share the trays 271provided with the RFID tags.

Although not illustrated in the drawings, the storage unit 263 isprovided with the mechanism which sets the samples from the conveyanceline 268 to the trays 271, and the preprocess-finished samples conveyedto the storage unit 263 are transferred from the conveyance line 268 andinstalled on the trays 271 installed in the storage unit 263.

The LIS 270 orders an add-on test(s) and addition of a test item(s) forany of the samples installed on the trays 271 of the storage unit 263,and it is transmitted to the operation unit 267 of the sample testautomation system 260.

A test technician takes out the tray 271 from the storage unit 263without changing the state in which the samples are installed thereon.The point when this taking out operation is carried out triggers (forexample, the RFID tag is provided on the tray, an RFID antenna isinstalled in the apparatus side in which the tray is installed, and astate in which the tag starts moving to be separated from the antennaserves as a trigger) the antennas 274 (RFID transmitting/receivingantennas) installed in the storage unit 263 to receive theidentification information of the tray 271 from the RFID tag thereof(herein, those including an RFID tag reader are described as an“antenna”) and store the information, and, at the same time, theidentification information of the taken-out tray 271 is transmitted fromthe storage unit 263 to the operation unit 267. In the operation unit267, if it is identified that the samples installed on the tray 271include the sample (s) for which the add-on test or addition of the testitem has been ordered according to the above-described identificationinformation, this is screen-displayed by the monitor 264 to inform thetest technician, and sounds are generated by the speaker 265.

The test technician receives the notification generated from the monitor264 and the speaker 265 and installs the tray 271 in the introducingunit 261 without changing the state thereof. In this process, theantennas 274 installed in the introducing unit 261 read theidentification information of the tray 271, the sample(s) for which theadd-on test and addition of the test item has been ordered isidentified, and only this sample(s) is immediately transferred from thetray 271 to the conveyance line 268.

In some cases, an add-on test (s) and addition of a test item(s) isordered for the sample (s) of the tray 271 after the tray 271 has beentaken out from the storage unit 263. Therefore, the test technician alsointroduces the trays 271, for which time has elapsed for a while aftertaking it out from the storage unit 263, into the introducing unit 261again. However, also in the case in which there is no sample to betransferred again to the conveyance line 268 since it is a tray in whichthe samples to be subjected to add-on tests and addition of test itemsare not installed in reality, in the operation unit 267, based on theidentification information of the tray 271 transmitted from theintroducing unit 261, this is screen-displayed by the monitor 264 fornotifying the test technician of this, and also sounds are generated bythe speaker 265.

Therefore, there is no need to search at which position in the taken-outtray 271 the sample for which the add-on test or addition of the testitem has been ordered is placed, and simplification and authenticity ofoperations can be ensured.

In this process, it is desired that the screen display and the soundsfor notifying that the samples, which are to be re-introduced because ofthe add-on test and addition of the test items, are installed on thetray 271 when the tray 271 is taken out from the storage unit 263 andthe screen display be mutually different type from the sounds fornotifying that the samples, which are to be re-introduced because of theadd-on test and addition of the test items, are not installed on thetray 271 even when the tray is introduced into the introducing unit 261.

In normal clinical test management, add-on tests and addition of testitems should be processed at higher priority than that of first tests(routine samples which are not treated as STAT). Therefore, in theintroducing unit 261, the most efficient transfer of the samples to theconveyance line 268 is achieved by cooperation with the operation unit267 while understanding the introduced state of the samples.

FIG. 21 shows a judging process 290 for achieving the above-describedprocess by the introducing unit 261. Although it is not illustrated inthe drawings, other than the locations for installing the trays, theintroducing unit 261 is provided with an STAT sample installation unitas a location for installing, by manual operation, the STAT samples forwhich test implementation is hurried (hereinafter, described as STATsamples) and supplying the samples to the conveyance line 268 in aprioritized manner. The samples installed in the STAT sampleinstallation unit are processed as a first priority; and, after thesamples installed in the STAT sample installation unit are eliminated,the process proceeds to a process of transferring (reformatting) thesamples from the trays set in a tray installation unit of theintroducing unit 261 (steps 291, 292).

The identification information of all the trays and the samplesinstalled on the trays in the introducing unit at this point iscomprehensively judged, and a process of transferring only the samplesfor which add-on tests and addition of test items have been ordered fromthe trays on which the samples for which the add-on tests and additionof the test items have been ordered to the conveyance line 268 iscarried out first (step 293, 294).

Then, a process of transferring routine samples from the trays on whichthe samples of first tests (routine samples) are installed to theconveyance line 268 is carried out, and the process 290 thereof isrepeatedly carried out until the apparatus is stopped (steps 295, 296,297).

In the above-described embodiment, management of re-introducing thetrays 271 from the storage unit 263 to the introducing unit 261 in thesingle sample test automation system 1 has been described. However, thecase in which a plurality of sample test automation systems arecontrolled by the single operation unit can also employ the managementof introducing the trays 271 taken out from the storage unit 263 to theintroducing unit 261 of the other sample test automation system mutuallyamong the plurality of sample test automation systems. Also in the casein which operation units are installed in a plurality of sample testautomation systems, respectively, similar management can be carried outby carrying out appropriate cooperation among the operation units.

FIG. 22 shows two sample test automation systems 501 and 502. The sampletest automation systems 501 and 502 are respectively provided withoperation units 303 and 306 and appropriately cooperate with each otherby using communication means 266. The tray on which preprocess-finishedsamples are installed is taken out from a storage unit 302 in the sampletest automation system 501 and introduced to an introducing unit 304 ofthe next sample test automation system 502, thereby carrying out apreprocess to be processed in the sample test automation system 502.

Like this management mode, the system positioned as a second orsubsequent system is sometimes referred to as a “postprocess” systemsince it does not carry out a preprocess.

In the above-described embodiment, passing of the trays among theplurality of sample test automation system has been described. However,also when passing the preprocess-finished tray to a stand-aloneapparatus (for example, an automatic analyzing apparatus), an apparatuswhich reads/writes the identification information is attached to thestand-alone apparatus side so that the information can be passed and theprocess can be continued.

Examples of the stand-alone apparatus include an aliquoting apparatuswhich works alone other than the automatic analyzing apparatus.

In another embodiment, generally, one tray on which samplescorresponding to a predetermined number of tubes can be installed isused as one sorting destination group in a general example. However,regarding the samples corresponding to a test item for which tests arenot frequently requested among the whole processing samples of one day,the number of the samples sometimes does not satisfy the total number oftubes which can be installed on the tray. In such a case, a plurality ofpositions on the tray are sectioned into particular areas to carry outmanagement of assembling sorting groups.

As an embodiment, FIG. 23 illustrates a state in which a tray 311 onwhich 50 samples can be installed in “5 columns”×“10 rows” is lookeddown from directly above. As an example of the above-describedmanagement, as surrounded by a broken line 312, the left-side threecolumns are used as one group, and the right-side two columns are usedas a sorting destination of another group. When using the management ofsectioning a tray into a plurality of areas, management of providing adedicated tray by carrying out coloring for distinguishing the tray soas to, for example, color the left-side three columns in red and colorthe right-side two columns in blue in order to facilitate understandingof the test technician and fixing the installation position of the trayin the tray installation base 273 is ubiquitous (assuming managementthat facilitates a user to understand the installation locations on thetray installation base by coloring and distinguishing the tray side).

Therefore, in the present invention, in the operation unit in advance,sensor position information (sensor is not illustrated in the drawings)indicating tray installation positions on the installation base, traytype information indicating vertical/horizontal sizes of the installedtrays, and the range information of identifier numbers (tray IDs) of thetrays installed on the sensor positions are set as parameters in theoperation unit 267. Then, when the dedicated tray of the test technicianis installed in the installation area of the storage unit, rationalitycheck of the identifier of the tray and the above-described parametersis carried out; and, if irrational, alarms are generated by the monitor264 and the speaker 265 to notify the test technician of the fact thatthe type of the installed tray and the installation position of the trayare wrong.

FIG. 24 illustrates a display screen example 320 of the above-describedparameters displayed by the monitor 264. Although detailed descriptionswill be omitted, as shown by a broken line 321, for the installationposition at which the sensor position is 8, usage of a divided trayincluding “3 columns”×“10 rows” and “2 columns”×“10 rows” and the IDrange of the tray are set as parameters.

According to another embodiment, the samples collected since apreprocess thereof is interrupted due to some sort of errors aretransferred to the trays 271 installed in the introducing unit 261 andthe storage unit 263, and the samples are collectively set in individualareas of each tray 271 depending on the substances of the errors.

The substances of the errors include that a state in whichre-introduction cannot be carried out before taking out the sample bymanual operation and removing, for example, clogging components like analiquoting error; while an arrival check time-out error sample for whichrequest attribute information has not been transmitted from LIS 270within determined response time does not require treatment and is in astate the sample can be re-introduced without change.

The samples in the state in which they do not require treatment and canbe subjected to retry of re-introduction without change as describedabove are also collectively transferred to a predetermined area of thepredetermined tray 271 set in advance, and the identificationinformation of the samples are stored in the identifier of the tray 271.

When the test technician takes out the tray 271 from the predeterminedposition of the introducing unit 261 or the storage unit 263 andre-introduces the tray to the introducing unit 261, the samplescollected by the arrival check time-out error are transferred to theconveyance line 268 again.

The samples for which the request attribute information has beennormally transmitted as a result of the re-introduction described aboveare subjected to a normal preprocess without change. The samples whichundergo arrival check time-out errors again are sorted and separated notinto the area of the arrival check time-out errors in the predeterminedtray, but into an area in which treatment is not required due to nocorresponding request so that re-introduction is not carried out, whichis also effective as a management method.

A next embodiment uses management of initializing the information storedin the identifier of the tray 271 to provide a new tray 271 and settingnew samples thereon; therefore, the operation unit 267 is provided witha tray information initializing screen 322 as illustrated in FIG. 25.After inputting a number (not illustrated in the drawings) imparted tothe used tray 271 to a screen, a user sets new processing samples on thetray 271 and introduces the tray to the introducing unit 261; as aresult, the information stored in the identifier of the tray 271 isinitialized, and the tray 271 is repeatedly used. Alternatively, all ofthe processing samples are removed from the tray 271 for whichinitialization has been ordered by the screen, and the tray 271 is setin the storage unit 263; as a result, the information stored in theidentifier of the tray 271 is automatically initialized, and the tray271 is repeatedly used.

In another embodiment, the identifier of the tray 271 stores the date ofthe stored date of a primary sample and is provided with parameters forsetting a tray expire date in advance; and, in the operation unit 267,optical values for management can be set by a user as the parameters bya tray expire date parameter screen 323 as illustrated in FIG. 26. Inthe screen example as illustrated in FIG. 26, mutually different expiredates can be set respectively for the tray ID ranges. The tray 271 whichhas exceeded the tray expire date can be judged to have exceeded theexpire date by the number of elapsed days according to the date ofstorage on the identifier and the current date and by set values of theparameters; as a result, the information stored in the identifier of thetray 271 is automatically initialized.

Since initialization is automatically carried out in this manner, thetray 271 which has been perceived by the user in advance that the expiredate has been exceeded can be subjected to the management of installingnew processing samples thereon and directly setting the tray to theintroducing unit 261 or removing all of the processing samples therefromand setting the tray to the storage unit 263 without operating the trayinformation initializing screen 322.

According to another embodiment, the “previously installed location” ofthe tray 271 is stored in the identifier of the tray 271, the emptiedtray 271 installed in the introducing unit 261 and emptied afterfinishing introducing processing management of samples is treated as“new” when installed in the introducing unit 261 again, the informationonce stored in the identifier is initialized, and the installationinformation is then stored again in the identifier. In such anembodiment, regulations in the management are generated so thatre-installation to the introducing unit 261 is always treated as “new”.As a result of providing such regulations, labor can be saved byautomatically initializing the identifiers of the trays 271.

Also, by detecting that no samples are placed on the tray 271 to beinstalled in the storage unit 263 by using a CCD camera, which ishardware not illustrated in drawings, the information stored in theidentifier of the tray 271 can be automatically initialized.

Also, by detecting that no sample is placed on the tray 271 to beinstalled in the storage unit 263 by using a weight detector, which ishardware not illustrated in the drawings, the information stored in theidentifier of the tray 271 can be automatically initialized.

According to the foregoing embodiments of the sample test automationsystems, the following effects can be achieved.

The trays are handled in order to minimize the frequency of directcontact between the test technician and the samples. As a result, simpleoperations are realized, mix-up of samples and delay of test resultswhich are human errors can be prevented, and the risk of infection canbe avoided.

FIG. 27 is an overall schematic diagram of a test sample automationsystem according to an embodiment of the present invention.

The sample test automation system 351 according to the presentembodiment is composed of: a sample introducing unit 410; a centrifugalunit 420; a decapping unit 430; a barcode attaching unit 440; analiquoting unit 450; a recapping unit 460, a sorting unit 470, a samplestorage unit 480; a conveying unit 352, an operation unit 490, a systemcontrol unit 491, and an error notifying unit 492.

In this case, after samples are taken into the system from the sampleintroducing unit 410, the samples stop by at the centrifugal unit 420,the decapping unit 430, the barcode attaching unit 440, the aliquotingunit 450, and the recapping unit 460, and the samples then go to thesorting unit 470 or the sample storage unit 480. If some sort of erroroccurs in the process of processing the samples, the system control unit491 perceives this, and the samples are carried out to an error samplecarrying-out destination in the system.

In some systems, an analyzing apparatus is connected, and, in that case,part of the samples are conveyed to the analyzing apparatus andsubjected to various analytical processes.

The sample test automation system 351 of the present embodiment often isa horizontally-long system, and the length thereof is over ten meters insome cases. Therefore, in a frequently generated operation, the distanceof moving is preferred to be as short as possible. The presentembodiment is characterized in that, in order to reduce the load of theoperator, the carrying-out destination of the error sample can bearbitrarily selected from a plurality of destinations, and the movingdistance of the operator is shortened as much as possible.

The sample introducing unit 410 is installed mainly in order to carry insamples from outside mainly into the sample test automation system 351.In this embodiment, the sample introducing unit 410 also has a functionof carrying out the samples in the system to outside.

A configuration of the sample introducing unit 410 will be explained byFIG. 28.

The configuration is composed of: first sample trays 520 on which samplecontainers 550, which are to be introduced into the system after thispoint of time, are collectively installed; first sample trayinstallation units 510 on which the first sample trays 520 areinstalled; second sample trays 521 on which sample containers taken outfrom the system are collectively installed; second sample trayinstallation units 511 on which the second sample trays 521 areinstalled; an arm unit 530 a, which moves the samples from the firstsample trays 520 to sample holders 540 and moves the samples from thesample holders 540 to the second sample tray 521; an in-module conveyingunit 421, which moves the sample holders 540 from/to the conveying unit352; and a sample identifier reading unit 422, which reads identifiers423.

Both of the first sample trays 520 and the second sample trays 521 aresupporters for retaining the samples, and holes for retaining thesamples are disposed in a plurality of columns. FIG. 32 shows an exampleof the sample tray on which holes are arranged like a lattice of n-rowsand m-columns. FIG. 36 shows an example of the sample tray of anarrangement in which each column or each row of the holes is shifted.This case can be treated by a similar idea as that of the lattice-likesample tray by considering the zigzag-arranged holes as one row or onecolumn; therefore, hereinafter, the lattice-like sample tray will betaken as an example to explain. Each of the holes is present forinserting the sample container, and the inserted sample is maintainedsubstantially upright without falling down. Each of the holes isconfigured so that a normally-used test tube having a diameter of 9 mmto up to 17 mm can be maintained upright, and even sample containershaving different diameters can be installed on the single sample tray.

The first sample trays 520 can be removed from the sample introducingunit 410. The first sample tray 520 is convenient for collectivelyinstalling about several tens or several hundreds of sample containers550, which are to be processed after this point of time, on a workingtable in a test room.

The operator places the first sample tray 520 near a reception locationof a test room, and the samples of which reception checking operationhas been finished are sequentially set on the first sample tray 520. Ata point when a certain amount of samples are stored, the operator setsthe first sample tray 520 to the first sample tray installation unit 510of the sample introducing unit 410.

Then, the arm unit 530 a holds and lifts up the container sequentiallyfrom the sample container 550 installed on either one of the back sideor front side of the first sample tray 520 seen from the operator andmoves and installs the sample to the sample holder 540 waiting on thein-module conveying unit 421.

The identifier 423 for distinguishing from other samples is attached onthe sample container 550. The sample identifier reading unit 422 readsthe identifier 423 attached on the sample container 550 when the sampleholder 540 passes the vicinity of the sample identifier reading unit422.

At this point, a situation that the identifier 423 of the sample cannotbe read due to some sort of error occurs. If the identifier 423 of thesample is a barcode label, for example, taint of the barcode label,defective printing, defective attaching such as tilted attaching orpartial peel-off, or forgotten attaching is conceivable. In this case,the system control unit 491 cannot judge what kind of process should becarried out for the sample container 550. Therefore, the system controlunit 491 recognizes the sample container 550 as an error sample andconveys the sample to a location different from that of normal samples.

The operator has to carry out a recovery process for continuing theprocess of the error sample. The operator prints/creates the identifier423 of the sample again by a barcode printer, pastes that on the samplecontainer, and introduces the sample again from the sample introducingunit 410 into the system.

Based on the information of the read identifier 423 of the samplecontainer 550, the system control unit 491 has to judge and determinewhich processing module the sample should stop by and what kind ofprocess should be carried out. For this purpose, the system control unit491 obtains information about the sample from a test room informationsystem while using the identifier information of the sample as a key.However, a situation that the information about the sample cannot beobtained due to some sort of error can occur. An example thereof is asituation in which reply of the information in the test room informationsystem side is not on time, and time-out occurs. In that case, thesystem control unit 491 recognizes this sample as an error sample andconveys the sample to a location different from that of normal samples.

One of recovery processes of such an error sample is to re-introduce thesample again from the sample introducing unit 410 after the operatorinputs information about the sample from the operation unit 490. Anothermethod is to introduce the sample again from the sample introducing unit410 at the point when a measure against the error can be taken on thetest room information system side.

Then, the sample is conveyed to the centrifugal unit 420 via theconveying unit 352. The centrifugal unit 420 subjects the sample to acentrifugal separation process. The centrifugal unit 420 is composed of:a first sample holder buffer for standby of a sample holder which iswaiting for the centrifugal separation process; a centrifugal bucket, inwhich the sample to be subjected to centrifugal separation is installed;a second sample holder buffer for standby of an empty sample holder forinstalling the sample of which centrifugal separation process has beenfinished; and a centrifugal arm unit for moving the sample.

One of the errors that could occur herein is centrifugal interruption.Some sort of error occurs in the system side, and the centrifugalseparation process is interrupted in coordination with that. In thatcase, the system control unit 491 recognizes this sample as an errorsample and conveys the sample to a location different from that ofnormal samples. A recovery process for such an abnormal sample is tojudge necessity of centrifugal separation by the operator and subjectthe centrifugal-required sample to a centrifugal separation processmanually. The operator introduces the processed sample again from thesample introducing unit 410.

Then, the sample is conveyed to the decapping unit 430 via the conveyingunit 352. The decapping unit 430 is installed to automatically remove acap, which is attached in order to protect the sample, so that variousprocesses can be carried out in various processing units stopped byafter the decapping unit 430.

One of the errors that could occur herein is decapping failure. This isa case in which a decapping process cannot be carried out well due tosome sort of cause that, for example, slippage occurs when the cap is tobe held or the cap per se is broken. In that case, the system controlunit 491 recognizes this sample as an error sample and conveys thesample to a location different from that of normal samples. A recoveryprocess for such an error sample is that the operator subjects thesample to a decapping process by manual operation. The operatorintroduces the processed sample again from the sample introducing unit410.

Then, the sample is conveyed to the aliquoting unit 450 via theconveying unit 352. Aliquoting refers to an operation of separating asample in one primary sample container into small portions in aplurality of sample containers and is normally carried out by using apipetter. Herein, the primary sample container is referred to as a firstsample container, and the sample containers serving as destinations ofseparation into small portions are referred to as second samplecontainers. The aliquoting unit 450 automatically subjects the singleand plurality of second sample containers to an aliquoting process fromthe sample in the first sample container in accordance with an orderfrom the system control unit 491.

The second sample containers include sample containers of a test tubetype normally having a height of about 70 mm to about 105 mm, a cup typehaving a height smaller than that, and sample containers of abottom-raised test tube type having an outer shape like a test tubehaving a height of about 70 mm to 105 mm and having a container bottomhigher than that of a normal test tube. If the second sample containeris the test tube type or the bottom-raised test tube type, normally, anidentifier such as a barcode is printed and attached by the barcodeattaching unit 440 around the aliquoting process so that the sample canbe identified in the automatic analyzing apparatus side.

One of the errors that could occur herein is aliquoting failure. Thealiquoting failure is that the ordered amount of the sample cannot bealiquoted to the second sample container due to deficiency of the sampleper se in the first sample container or influence of foreign matters inthe sample. In that case, the system control unit 491 recognizes thesample as an error sample and conveys to a location different from thatof normal samples. The second sample containers related to the firstsample container are collectively conveyed to the same location. Arecovery process for such an error sample is that the operator carriesout an aliquoting process by manual operation. The operator introducesthe processed sample again from the sample introducing unit.

Furthermore, one of the errors that could occur herein is an identifiererror. The identifier error is failure of preparation of the identifierto be attached on the second sample container, which is a barcode labelin this case. Normally, conceivable examples include failure of barcodeprinting, tearing of barcode label paper, and attaching failure. In thatcase, the system control unit 491 recognizes this sample as an errorsample and transfers the sample to a location different from that ofnormal samples. A recovery process for such an error sample is that theoperator prints and pastes a barcode label by manual operation. Theoperator introduces the processed sample again from the sampleintroducing unit 410. Another method is to introduce the original firstsample container again from the sample introducing unit 410 to startover including aliquoting. The operator carries out the recovery processin either method.

Then, the sample is conveyed to the recapping unit 460 via the conveyingunit 352. The recapping unit 460 automatically recaps a cap to thesample container and protects the sample from evaporation and impuritycontamination.

One of the problems that could occur herein is recapping failure. Thiscorresponds to a situation in which a recapping process cannot becarried out well due to some sort of cause such as slippage of a cap orbreakage of the cap per se. In that case, the system control unit 491recognizes this sample as an error sample and conveys the sample to alocation different from that of normal samples. A recovery process forsuch an error sample is that the operator subjects the sample to arecapping process by manual operation. The operator introduces theprocessed sample again from the sample introducing unit 410.

Then, the sample is conveyed to the sorting unit 470 via the conveyingunit 352. Sorting refers to an operation of rearranging the samplesdepending on the purpose of usage or the destination.

An overview of the sorting unit 470 is illustrated in FIG. 29.

The sorting unit 470 is composed of: the in-module conveying unit 421,which conveys the sample-installed sample holders 540 from the conveyingunit 352 into the module; the second sample trays 521, on which theplurality of sample containers are collectively installed; the sampletray installation units 511 on which the plurality of second sampletrays 521 are installed; the arm unit 530 b, which moves the samplesfrom the sample holders 540 to the second sample trays 521; and anidentifier reading unit 515, which automatically reads the identifiersattached to the second sample trays 521.

The second sample tray 521 can be detached from the sorting unit 470.The plurality of sample containers 550 can be installed on the secondsample tray 521, wherein about several tens to several hundreds ofsamples can be collectively installed. Before starting operation, theoperator sets the second sample tray 521, on which no sample isinstalled, in the second sample tray installation unit 511.

In the sorting unit 470, when the sample that requires sorting flows atthe conveying unit 352, the system control unit 491 conveys the sampleholder 540 thereof from the conveying unit 352 into the module via thein-module conveying unit 421.

The arm unit 530 b holds and lifts up the sample on the sample holder540 and moves the sample to one of the plurality of second sample trays521. The second sample tray, which is the move destination, isdetermined in accordance with the parameters set by the operation unit490.

This sorting operation is repeatedly carried out until the second sampletray 521 becomes full. When the tray becomes full of samples, an alarmis generated to urge the operator to replace the second sample tray 521.The foregoing description is the explanation of normal operation of thesorting unit 470.

Next, a situation in which the sorting operation fails due to some sortof error will be explained. One of the errors that could occur herein isfailure of the sorting operation. Examples of the failure of the sortingoperation include that the arm unit 530 b fails to hold the sample. Inthat case, the system control unit 491 recognizes this sample as anerror sample and conveys the sample to a location different from that ofthe normal sample. A recovery process for such an error sample is tointroduce the sample again from the sample introducing unit after theoperator removes the cause of the sorting operation failure or to carryout the sorting operation per se by the operator instead of theapparatus.

Then, the sample is conveyed to the sample storage unit 480 via theconveying unit 352. This state occurs only when the sample has not beensorted by the sorting unit 470.

Storage refers to the operation of rearranging the process-finishedsamples depending on the types of the samples and carrying-out/storingthe samples to the sample trays. The configuration of the sample storageunit 480 is basically the same as that of the sorting unit 470. Adifference is that more second sample trays 521 serving as thecarrying-out destination of samples can be installed than in the sortingunit 470, the sample storage unit 480 can retain the second sample tray521 corresponding to one thousand samples in total while the sortingunit 470 retains the second sample trays 521 corresponding to severalhundreds in total.

The outline of the processes of the samples has been explained above. Ithas been described therein that the sample recognized as the errorsample is conveyed to the location different from that of normalsamples, and details thereof will be explained subsequently.

First, in the present embodiment, in the sample introducing unit 410,the first sample tray 520 for introducing the sample from outside thesystem to inside the system can be utilized as the second sample tray521 for taking out the sample from inside the system to outside thesystem. Both of these have the same shape and can be mutually replaced.More specifically, when the sample tray is set in the first sample trayinstallation unit 510 of the sample introducing unit 410, the sampletray functions as the first sample tray, i.e., a sample tray forcarrying-in; and, reversely, when set in the second sample trayinstallation unit 511, the tray functions as the second sample tray 521,i.e., a sample tray for carrying-out. Furthermore, the sample trayinstallation units can be also switched by parameter setting of theoperation unit 490 and can be utilized as the first sample trayinstallation unit 510 for carrying in the samples and also as the secondsample tray installation unit 511 for carrying out the samples. In atest room having a high demand for the processing ability thereof, inwhich samples are desired to be collectively introduced at one time, allof the sample tray installation units are set as the first sample trayinstallation units 510. Reversely, when the processing ability is notrequired so much, part of them is set as the second sample trayinstallation unit 511 to take out error samples to the sampleintroducing unit 410; as a result, re-introduction of the samples aftererror recovery processes can be carried out on site.

In the sample test automation system 351 of the present embodiment, thesecond sample tray installation units which carry out the samples in thesystem to outside the system are present in the sample introducing unit410, the sorting unit 470, and the sample storage unit 480. Not onlynormal samples but also error samples can be carried out.

The error sample carrying-out destination can be set for each type ofthe errors and each method of the recovery processes.

As already described, there are several types of the error samples, andthe methods of the recovery processes are different depending on thetypes of the errors. When the error samples are carried out to onelocation, the operator can collectively process them; on the other hand,it is not known in some cases that what kind of errors happened to thesamples and what kind of recovery processes have to be carried out. Inthat case, the operator has to carry out recovery processes afterseeing, on the screen of the operation unit or a record file, what kindof processes should be carried out for which sample; resulting in aninconvenience. Therefore, the present embodiment provides a method bywhich the operator can collectively carry out operations at one locationand can perceive what kind of process should be carried out only byseeing the samples.

In the present embodiment, the carrying-out destinations of the errorsamples are specified to different locations, i.e., the sample trays orregions in the sample trays respectively for the types of the errors.Furthermore, what kind of error samples are to be carried out is storedin advance in the carrying-out destination by means of, for example,characters or colors which can be distinguished by the operator. As aresult, the operator is enabled to perceive the type of the error fromthe conveyed location and judge what kind of operation should be carriedout to carryout the recovery processes without seeing the screen orrecord file.

Furthermore, another example is a method in which the carrying-outdestinations of the error samples are specified respectively for themethod of the recovery processes instead of the types of the errors. Inthis case, if the recovery process methods are the same even in theerrors of different types, the operator is not required to distinguishthe error samples; therefore, the purpose to enable the recoveryprocesses without seeing the screen or record file can be achieved.

Options for setting the carrying-out destinations of the error sampleswill be described below.

One of them is the unit of the second sample tray installation unit 511.Several tens of samples can be collectively taken out to the secondsample tray 521. A large amount of reset samples are generated at onetime after forcible stop of the apparatus occurs; therefore, it isconvenient to take out such samples. If necessary, the carrying-outdestination of the error samples of the same type can be specified forthe plurality of second sample tray installation units 511 so that theerror samples can be carried out across to the plurality of secondsample trays 521.

Another one is to logically fragment the second sample tray 521 so thatthe carrying-out destinations of the error samples can be specified inthe position units in the tray. In this case, the setting contents ofthe parameters are the second sample tray installation unit 511 and thepositions in the second sample tray 521 installed therein.

In the setting screen of the operation unit 490, information of fourtypes is associated to specify error conveyance destinations. The fourtypes of information are: error-sample type information for specifyingthe types of the error samples, error-sample carrying-out-destinationmodule information for specifying the modules serving as thecarrying-out destinations of the error samples, sample tray installationunit information for specifying the carrying-out-destination sample trayinstallation unit in the module, and positions in the error-samplecarrying-out-destination sample tray. FIG. 30 shows an example ofsetting in which carrying-out destinations are specified for the typesof the error samples, respectively.

FIG. 31 shows the carrying-out destinations of the error samplesaccording to the setting illustrated in FIG. 30.

Among the samples for which errors have occurred, the samples ofsample-identifier unreadable 210, sample-information unobtainable 220,and decapping process failure 240 are carried out to the sample tray forcarrying out error sample, i.e., the second sample tray 521 installed ona sample tray installation unit 413 of the sample introducing unit 410.

Among the error-occurred samples, the samples of aliquoting failure 250are carried out to the sample tray for carrying out error sample, i.e.,the second sample tray installed on a sample tray installation unit 412of the sample tray introducing unit 410.

Among the error-occurred samples, the samples of centrifugal separationprocess interruption 230 are carried out to the sample tray for carryingout error sample, i.e., the second sample tray installed on a sampletray installation unit 481 of the sample storage unit 480.

All of them are positioned near a sample tray installation unit forsample introduction, in other words, a first sample tray installationunit 411 and are at the positions from which re-introduction can beeasily carried out after error recovery processes are finished.

FIG. 32 shows details of the second sample tray 521 to which the samplesof the sample-identifier unreadable 210, the sample informationunobtainable 220, and the decapping process failure 240 are carried out.Based on the information set in FIG. 32, the system control unit 491carries out the error samples to the second sample tray 521 set in thesecond sample tray installation unit 413 of the sample introducing unit410.

The second sample tray 521 is a sample tray having holes for insertingsample containers in 5 rows and 10 columns. The tray has samplecontainer installation holes at 50 locations in total starting from theright bottom of FIG. 32 and ending at the upper left of FIG. 32.

A first region 660 has test-tube installation holes at positions 1 to20, and only the samples of the sample-identifier unreadable 210 areinstalled therein.

A second region 670 has test-tube installation holes at positions 21 to40, and only the samples of the sample-information unobtainable 220 areinstalled therein.

A third region 680 has test-tube installation holes at positions 41 to50, and only the samples of the decapping process failure 240 areinstalled therein.

An embodiment about replacement of the second sample tray 521 serving asthe carrying-out destination of the error samples will be describedbelow.

An identifier 701 is attached on the second sample tray 521. Theidentifier 701 is read by the identifier reading apparatus 515 at thepoint when the second sample tray 521 is set to the second sample trayinstallation unit 511 and is transmitted to the system control unit 491.Based on this information, after replacement of the second sample tray521, the system control unit 491 judges how samples are remaining on thesecond sample tray 521.

A first method will be described. In the system control unit 491, basedon the last initialization of a database about the sample trays or thepoint of time when date is changed, if the identifier 701 of the secondsample tray 521 is the identifier read first time thereafter, it isjudged that an empty second sample tray from which all samples have beenremoved is installed, and samples are carried out from the firstposition. Reversely, if an identifier which has once recognized is read,it is judged that the second sample tray 521 which has been used once isinstalled again, and samples are sequentially installed thereon from aposition on the sample tray next to the position from which the samplehas been carried out the last time. Conceiving the case in which thesame sample tray has to be used several times, a sample-tray resetordering unit is provided on the operation screen or near the secondsample tray. When this is implemented, the system control unit 491judges that the second sample tray has been emptied and forcibly carriesout samples from the first position.

A second method will be described. In a certain second sample trayinstallation unit 511, the identifier 701 of the second sample tray isdifferent before and after replacement of a second sample tray 300, thesystem control unit 491 judges that all the samples on the second sampletray have been removed and carries out the samples from the firstposition. Reversely, if the identifier 701 is the same before and afterreplacement of the second sample tray 521, it is judged that the samesecond sample tray has been installed, and the samples are sequentiallycarried out from the position next to the position where the sample waspreviously placed last time. Also in this case, similarly, conceivingthe case in which the second sample tray of the same identifier has tobe used several times, the sample-tray reset ordering unit is providedon the operation unit screen or near the second sample tray. When trayreset is implemented, the system control unit 491 judges that the secondsample tray has been emptied, and the samples are forcibly carried outfrom the first position.

These two methods are embedded in the system control unit 491 in advanceso that they can be switched in the operation unit.

Notification of error occurrence will be described.

The sample test automation system 351 of the present embodiment isprovided with the error notifying unit 492, which notifies the operatorof occurrence of errors. Conceiving that the operator is not always nearthe sample test automation system 351, a method capable of giving anotification to a distant location by a sound outputting device or alight outputting device is preferred as a communication means. Theerrors of the processes with respect to the samples occur in theprocessing units as described above, and carrying-out destinations ofthe error samples can be selected from a plurality of locations for theconvenience of the operator. Therefore, the location of error occurrenceand the carrying-out destination of the error sample are not alwaysclose to each other. For example in the aliquoting error, it is a casein which the sample of the aliquoting error is carried out to the sampleintroducing unit although the aliquoting error has occurred in thealiquoting unit 450.

In this case, a time lag of about several tens of seconds may begenerated before the sample is carried out to the error carrying-outdestination after the error has actually occurred. If the errornotifying unit 492 immediately notifies the operator of the error at thepoint when the error occurred, a situation occurs in which the errorsample has not been carried out yet even when the operator rushes to thecarried-out location of the error sample. In this case, the operator hasonce turned off the alarm and waits on site until the sample comes outor starts another task. If the other task has been started, start of aprocess may be delayed without noticing carry-out of the error samplesince the alarm has been turned off.

In order to avoid this, in the present embodiment, the timing of errornotification is at the point when the error sample is carried out to thesecond sample tray 521 instead of at the point of error occurrence. Thepoint of carrying-out referred to herein includes over ten secondsaround the point.

Furthermore, in this embodiment, the timing of alarm generation can beset from the operation unit 490. Options of the timing of alarmgeneration are immediately after the error occurrence or at the pointwhen the error sample is carried out to the second sample tray 521.

Furthermore, conceivable units of the alarm for which the alarmgenerating timing can be set are three types including the unit for allalarms and units which can be separately set for each alarm or for eachalarm of which recovery process method of error samples are the same.

A method of causing the sample test automation system 351 to carry out aprocess of a case when failure occurs again after an error has occurredwill be described.

Basically, if a process fails, the sample test automation system 351 ofthe present embodiment carries out the failed sample to outside of thesystem, and the operator manually carries out the process. When thesample is carried into the system again, the sample test automationsystem resumes the process that is subsequent to the failed process. Forexample, the processing units are sequentially arranged in the order ofthe sample introducing unit 410, the centrifugal unit 420, the decappingunit 430, the aliquoting unit 450, and the sample storage unit 480; and,in a case in which processes thereof are to be sequentially carried out,if an error occurs in the centrifugal unit 420, the operator manuallycarries out a centrifugal process for the sample, and, afterre-introduction, the sample test automation system continues the processfrom that of the decapping unit. However, in a situation in which acentrifugal separation process has not been carried out almost at allsince an error occurs for some reason immediately after centrifugalseparation is started, the operator may judge that the centrifugalprocess can be carried out again in the sample test automation system.This system provides means for forcibly carrying out the previouslyfailed process again in such a case.

A method to achieve this is a method that provides the first sample tray520 for forcible re-processing or the first sample tray installationunit 510. All of re-introduced samples carried-in therefrom areconfigured so that the process thereof is started again from theerror-termination-occurred process. This method is convenient in a casein which re-processing is collectively ordered at one time since thereis no need to repeatedly specify re-processing for any of the samplesfrom, for example, the operation unit screen. Particularly, several tensof error samples are generated at one time in the above-describedrecovery process after interruption of the centrifugal separationprocess; therefore, the present method is effective.

Another method to realize this is a method of providing a re-processingforcible ordering unit on the screen of the operation unit 490. Afterthe identifiers of the samples which are desired to be re-processed arespecified on the operation unit screen, re-processing is ordered fromthe re-processing forcible ordering unit. Then, when samples areintroduced, the re-processing is carried out only for the specifiedsamples. This method is convenient for re-processing errors of a smallnumber of samples caused by individual errors depending on the samples.Examples thereof include a case in which aliquoting fails in thealiquoting unit since foreign matters such as fibrin have precipitatedin the sample.

The ways of arranging the error samples which have undergone aliquotingfailure in the aliquoting unit 450 will be described.

In the sample test automation system 351 of the present embodiment, ifan error occurs upon aliquoting, the aliquoting process is interrupted,and the sample is returned to the first sample container which is asource thereof. At most ten second sample containers, which are thedestinations of separation into small portions, can be generated inaccordance with an order from the test room information system side;and, if aliquoting fails, all of them become empty. Furthermore, even inthe case in which aliquoting fails, the barcode labels serving as theidentifiers are attached on the second sample containers. On theidentifier attached on the second sample container, the ID forspecifying the sample, a sample ID, the amount of sample aliquoting,destination, and what analysis it is to be utilized are printed. Thisindicates that how much samples have been supposed to be aliquoted intothe second sample container if aliquoting is normally carried out. Thissupports the operator to carry out aliquoting by manual operation byseeing the numerical values thereof in the process of a recovery processof aliquoting failure without seeing the screen of the operation unit orprinted matter.

When the system control unit 491 recognizes occurrence of aliquotingfailure, the first sample container, which is the source, and all of thesecond sample containers related thereto or all of the aliquoting-failedsecond sample containers are conveyed to an error-sample conveyancedestination. Whether the conveyance targets for the error-sampleconveyance destination are to be all of the second sample containers orthe aliquoting-failed second sample containers can be also set from theoperation unit 490. In the error-sample conveyance destination, thefirst sample containers and the second sample containers are arranged onthe second sample tray 521 in the manner illustrated in FIG. 33.

FIG. 33 shows a state in which aliquoting-failed samples are arranged onthe second sample tray 521. The second sample tray has holes arranged ina lattice of 10 rows and 5 columns, and sample containers can beinserted therein, respectively. In this case, in total 50 samplecontainers can be installed on the second sample tray 521. Each of theholes is configured to retain a normally-used test tube having adiameter of 9 to 17 mm upright, and even sample containers havingmutually different diameters can be carried out onto the single secondsample tray. The first sample containers and the second samplecontainers are often mutually different types; therefore, it isessential that the test tubes having mutually different diameters can beinstalled on the single sample tray.

First sample containers 730 serving as aliquoting sources and secondsample containers 731 serving as destinations of separation into smallportions are arranged as illustrated in FIG. 33 according to rulesdescribed below.

One of the rules is that the containers of the first sample and thesecond sample are carried out to mutually adjacent positions. First,aliquoting failure occurs with respect to a certain sample, and there isa necessity of carrying out one first sample container and two emptysecond sample containers related thereto to the second sample tray. Inthis case, the first sample container is carried out to the first columnof the first row. Furthermore, the two second sample containers arecarried out to the second and subsequent columns in the same row as thefirst sample container without space therebetween. In this case, thecontainers are carried out to the second and third columns.

If the number of the second sample containers exceeds “the number ofcolumns −1”, the second sample containers are arranged from the firstcolumn of the next row. If the number of the second sample containers is6, the fifth and sixth second sample containers are arranged in thefirst column and the second column of the next row of the primarysample.

Another one of the rules is that, if the first sample containers servingas sources are different, the first sample containers are carried out tomutually different rows. If aliquoting failure newly occurs and thefirst sample container and the second sample containers related theretoare to be carried out, the containers are carried out after switching tothe next row even if vacant positions are still remaining in the row towhich the sample container has been carried out last time. The way ofarrangement upon carry-out has a rule similar to that of the previoussamples.

According to the above-described rules, first, the carrying-outdestinations are separated depending on the types of errors in thepresent embodiment; therefore, the operator can recognize that thecarried-out samples are those of aliquoting failure according to thecarried-out location. Furthermore, the first sample container serving asa source is always present in the first column, and the empty samplecontainers serving as destinations of separation into small portions arecollectively arranged in one location. Therefore, the operator caneasily find the first sample container and the second sample containerswhich are related to each other.

Furthermore, the aliquoting amount that has to be aliquoted from thefirst sample container to the second sample container by manualoperation is printed on the identifier attached on the second samplecontainer; therefore, after recognizing occurrence of an error by soundor light and rushing to the sample carried-out location, the operatorcan immediately start a recovery operation on site without seeing ascreen or a record file.

Furthermore, the second sample tray, which carries out aliquoting failedsamples, and the first sample tray, which re-introduces the samplesafter recovery processes, are set so as to be positioned close to eachother; as a result, the operator is not required to move but canre-introduce the samples on the site.

If a plurality of aliquoting failed samples are collectively present,the second sample tray to which the aliquoting failed samples have beencarried out can be detached, and the samples can be collectivelyprocessed on a working desk. Also in this case, operation can be carriedout without seeing a screen or a record file; therefore, operationefficiency is also good.

A method of efficiently sharing one carrying-out destination by twodifferent types of samples will be described.

The second sample tray serving as a carrying-out destination has holesarranged like a lattice having n-rows and m-columns, and sample traysare inserted thereinto, respectively. Two types of samples, i.e.,first-type samples and second-type samples are carried out to the secondsample tray for carrying out samples. The first-type samples are carriedout to the second sample tray sequentially from the front row thereof,and the second-type samples are carried out to the second sample traysequentially from the back row thereof. The sample of the first type andthe sample of the second type are installed until they are next to(adjacent to) each other, and the installation regions thereof aredynamically changed. Depending on changes in the situation of the testroom, the number of each type of the samples is increased/decreased. Inthis method, the second sample tray can be maximally effectivelyutilized in any situation.

Furthermore, improvement methods of the present embodiment will bedescribed.

In the previous example, the second sample tray can be maximallyutilized; however, since the boundary thereof is not clear, if there isno clear method to distinguish the two types of samples such asdifferent colors of caps or different shapes of sample containers, theoperator cannot easily judge where the boundary is. Therefore, in amodified embodiment, instead of installing the first-type error samplesand the second-type error samples until they are adjacent to each other,the samples are installed until they are adjacent to each other with oneor more holes for installing the samples or one or more vacant rowsprovided therebetween. At the point when the samples that exceed thiscondition are delivered, the sample test automation system gives anotification by some method that the sample tray has become full to urgethe operator to replace the tray. Even if the shapes of the samplecontainers of the first type and the second type are the same and cannotbe distinguished from each other, the operator can judge the vacancy asthe boundary.

FIG. 34 shows a case in which many first-type sample containers 740 havebeen sorted, and FIG. 35 shows a case in which many second-type samplecontainers 741 have been sorted. It can be understood that the boundaryis dynamically changed to sort more samples both in the case in whichthe number of the first-type sample containers 740 is large and the casein which the number of the second-type samples is large.

FIG. 37 shows an example in which the first-type sample containers 740and the second-type sample containers 741 are installed until they areadjacent to each other with one vacant row provided therebetween. Inthis state, if the next second-type sample containers 741 arrive, thecondition that “they are adjacent to each other with one vacant rowprovided therebetween” cannot be satisfied. At the point when the nextsecond-type sample containers arrive, an alarm indicating that thesample tray has become full is generated to urge the operator to replacethe sample tray.

The above-described first-type sample containers can be sorted as errorsamples, and the second-type sample containers can be sorted as normalsamples; and the first type and the second type can be sorted by thetypes of errors. Also, the samples which require add-on tests can besorted as the first type, and the samples which do not require add-ontests can be sorted as the second type. The way of sorting of these canbe determined by a user and stored in the system in advance, or aninterface by which the way of sorting can be selected by a user on ascreen may be provided.

While the invention made by the inventors of the present invention hasbeen concretely described based on the embodiments in the foregoing, itis needless to say that the present invention is not limited to theforegoing embodiments and various modifications and alterations can bemade within the scope of the present invention.

INDUSTRIAL APPLICABILITY

The present invention relates to sample test automation system and canbe widely applied particularly to a system, an apparatus, etc. whichcarries out conveyance by a sample holder on which only one sample isinstalled.

What is claimed:
 1. A sample test automation system for subjecting samples to various processes, the sample test automation system comprising: an introducing unit configured to hold a plurality of sample trays, each having one or more samples which are to be processed in the sample test automation system held in one or more sample containers placed thereon, wherein the introducing unit has a first sample transfer arm configured to separately transfer the sample containers between the sample trays held therein and a plurality of respective sample holders; a storage unit configured to hold a plurality of sample trays each having one or more samples which have been processed in the sample test automation system held in one or more sample containers placed on each of the sample trays, wherein the storage unit has a second sample transfer arm configured to separately transfer the sample containers between the respective sample holders and the sample trays held therein; a conveying unit configured to convey the sample containers in the sample holders to and from the introducing unit, destinations corresponding to the various processes, and the storage unit; and an operation control unit programmed to control the introducing unit, the storage unit and the conveying unit, wherein a plurality of tags including information for distinguishing the individual sample trays from the other sample trays are attached to the sample trays, wherein the introducing unit includes a plurality of tag readers and a plurality of tray storage units each having a shape to hold one of the sample trays and having one of the tag readers disposed therein, and each of the tag readers is configured to read one of the tags attached to one of the sample trays when the one of the sample trays is placed on a corresponding one of the tray storage units, wherein the storage unit includes a plurality of tag readers and a plurality of tray storage units each having a shape to hold one of the sample trays and having one of the tag readers disposed therein, and each of the tag readers is configured to read one of the tags attached to one of the sample trays when the one of the sample trays is placed in a corresponding one of the tray storage units and when the one of the sample trays is removed from a corresponding one of the tray storage units, wherein the operation control unit is programmed to control the second sample transfer arm to transfer the ones of the sample containers in the sample holders from the conveying unit to the sample trays in the storage unit and cause information of each of the samples in the sample containers placed on a same one of the sample trays in the storage unit to correspond to information in the tag of the same one of the sample trays in the storage unit, wherein, when the operation control unit receives an order for an add-on test or an additional test item for one of the samples, the operation control unit is programmed to determine the one of the samples is placed on one of the sample trays which was removed from the storage unit based on reading the tags of the sample trays held in the tray storage units of the storage unit and display a notification to place the one of the sample trays in the introducing unit, and wherein, when the one of the sample trays corresponding to the notification is placed in the introducing unit, the operation control unit is programmed to acquire the information of the read tag of the one of the sample trays placed on one of the tray storage units and control the first sample transfer arm to transfer the sample container holding the one of the samples corresponding to the order from the one of the sample trays to one of the sample holders based on the acquired information of the read tag.
 2. The sample test automation system according to claim 1, wherein, when the one of the sample trays corresponding to the notification is placed in the introducing unit, the operation control unit is programmed to control the first sample transfer arm to transfer only the sample container holding the one of the samples corresponding to the order from among the samples installed on the one of the sample trays corresponding to the notification based on the acquired information of the read tag.
 3. The sample test automation system according to claim 1, wherein, after the notification to place the one of the sample trays in the introducing unit is displayed, the operation control unit is programmed to display a notification that the samples held on the sample trays held on the tray storage units of the introducing unit do not include the one of the samples corresponding to the order based on the information read from the tags attached to the sample trays held on the tray storage units of the introducing unit.
 4. The sample test automation system according to claim 1, wherein, when the one of the sample trays corresponding to the notification is placed in the introducing unit, the operation control unit is programmed to control the first sample transfer arm to transfer the sample container holding the one of the samples corresponding to the order from the one of the sample trays to one of the sample holders at a higher priority than that of the sample containers holding routine samples of other sample trays held in the introducing unit.
 5. The sample test automation system according to claim 1, wherein the storage unit is located separately from the introducing unit. 